Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
This recall has been terminated (originally issued April 18, 2012).
- Company
- Abbott Laboratories Inc.
- Recall Initiated
- March 10, 2010
- Posted
- April 18, 2012
- Terminated
- April 18, 2012
- Recall Number
- Z-1434-2012
- Quantity
- 2718 (U.S. 652)
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Observed particulate matter in some reagent cartridges.
Distribution
US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
Lot / Code Info
Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
Root Cause
Material/Component Contamination
Action Taken
Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.